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United States · US · US:70771-1367_b4ac4791-5cb1-4199-b56f-4171fd16fc33
NIFEDIPINE
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1170771136701000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1367-0)
- ndc117077113671100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1367-1)
- ndc11707711367410 BLISTER PACK in 1 CARTON (70771-1367-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc117077113677300 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1367-7)
- ndc11707711367990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1367-9)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A210184
AB1AB1AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "I9ZF7L6G2L",
"rxcui": "7417",
"inchikey": "HYIMSNHJOBLJNT-UHFFFAOYSA-N",
"display_name": "NIFEDIPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"518d39af-0be1-acbc-e063-6294a90a4ada": {
"match": "brand_token",
"title": "NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [COUPLER LLC]",
"spl_version": "1",
"published_date": "2026-05-13"
}
},
"productid": "70771-1367_b4ac4791-5cb1-4199-b56f-4171fd16fc33",
"productndc": "70771-1367",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210184",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "30MG",
"product_no": "001",
"approval_date": "Jun 29, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "60MG",
"product_no": "002",
"approval_date": "Jun 29, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "90MG",
"product_no": "003",
"approval_date": "Jun 29, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "NIFEDIPINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210184",
"marketing_category": "ANDA",
"nonproprietary_name": "NIFEDIPINE",
"start_marketing_date": "20180818",
"active_numerator_strength": "90"
}Related drugs
Other records sharing ATC code C08CA05.
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